Rate RESPONSIVe Pacing in Patients With Permanent AF Underwent AV Node ABLation and bivEntricular Pacing (RESPONSIBLE)
RESPONSIBLE
Effect on Exercise Capacity of Fixed Rate Vs Rate RESPONSIve Pacing in Patients With Permanent AF and Left Ventricular Dysfunction Underwent Radiofrequency Atrioventricular Junction aBLation and bivEntricular Pacing (RESPONSIBLE Study)
1 other identifier
interventional
60
1 country
7
Brief Summary
The purpose of this study is to evaluate the effect on distance covered in a 6 minute walking test of Rate Responsive pacing in patients with permanent atrial fibrillation and reduced left ventricular ejection fraction treated with atrioventricular junction ablation and biventricular pacing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedNovember 30, 2015
November 1, 2015
1 month
January 30, 2015
November 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The distance covered during the 6-minute walking test
6 minutes
Study Arms (2)
RR on first
ACTIVE COMPARATORRate Response on first
RR off first
ACTIVE COMPARATORRate Response off first
Interventions
Rate Response function is turned on in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned off and the patient performs a second 6 minute walking test.
Rate Response function is turned off in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned on and the patient performs a second 6 minute walking test.
Eligibility Criteria
You may qualify if:
- Permanent, refractory atrial fibrillation treated with atrio-ventricular node ablation and biventricular pacing
- Left ventricular systolic dysfunction
- Ability to perform a 6-minute walking test
- Completion of the 18th year of age
You may not qualify if:
- Contraindications to 6 minute walking test
- IV NYHA Class
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Università Politecnica delle Marche
Ancona, Ancona, 60121, Italy
Policlinico S.Orsola-Malpighi
Bologna, Bologna, 40138, Italy
AO Pugliese-Ciaccio
Catanzaro, Catanzaro, 88100, Italy
Azienda Ospedaliera "Card. G. Panico"
Tricase, Lecce, 73039, Italy
Seconda Università Napoli - A.O. Monaldi
Naples, Naples, 80131, Italy
AOU "Maggiore della Carità"
Novara, Novara, 28100, Italy
Ospedale San Filippo Neri
Roma, Roma, 00135, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pietro Palmisano, MD
Azienda Ospedaliera "Card. G. Panico" - Tricase
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 4, 2015
Study Start
January 1, 2015
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 30, 2015
Record last verified: 2015-11